Establishment of the Drug Exposure Models in the Dosing Environment of Inhaled Preparations and Discussion on Contamination Prevention and Control Measures in the Dosing Procedure

Abstract

In order to discuss the contamination prevention and control measures in the dosing procedure of human pharmacokinetic and bioequivalence studies for inhaled preparations, a total of four drug exposure models of mometasone furoate aqueous nasal spray were established in the negative pressure dosing room and the airtight dosing room with sitting and standing positions for the drug administration, respectively. The samples collected from the relevant parts after drug exposure in the dosing environment were determined by high-performance liquid chromatography–tandem mass spectrometry. The contamination caused by drug scattering on the relevant parts was investigated. Under the four drug exposure models, the surfaces of the investigated parts near the spray site were significantly contaminated by scattered drug. The facilities, such as the negative pressure ventilation system and air shower, could not remove scattered drug from the contaminated surfaces, while the investigated parts protected by protective articles were not contaminated. The results indicated that it was effective to prevent and control the contamination caused by drug exposure and scattering in the dosing environment and avoid secondary contamination to the collected biological samples by reasonably arranging respective regions and personnel movements, properly wearing and removing protective articles, and timely and appropriate handling of unexpected drug exposure.